Functional Dyspepsia
Conditions
Keywords
dyspepsia, rabeprazole, Japan
Brief summary
The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia.
Interventions
DRUGRabeprazole
Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
DRUGPlacebo
Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
Sponsors
Eisai Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Participants diagnosed as Functional Dyspepsia according to Rome III criteria.
Exclusion criteria
* Participants with neuropsychiatric disorder. * Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Complete Dyspepsia Symptom Relief | Up to 8 Weeks (including 7 days prior) | The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Satisfactory Symptom Relief | Up to 8 Weeks (including 7 days prior) | The rate of satisfactory symptom relief according to the DSQ defined as scores of \<= 2 for all four major dyspepsia symptoms at week 8 and the diary recordings defined as a frequency of \<= 1 day for all four major dyspepsia symptoms during the 7 days before week 8. Lastly, treatment success according to the participants' impression questionnaire where participants answered yes or no when asked if given the choice, whether they would want to continue to take the study drug after clinical trial completion. Values presented as percentage of participants. |
Countries
Japan
Participant flow
Recruitment details
This study was recruited at 66 centers in Japan during the period of 21-April-2010 to 12-Aug-2011.
Pre-assignment details
Participants were initially enrolled into a 1- or 2-week run-in period (single-blinded administration of placebo). Participants who did not respond to placebo were randomized to an 8-week treatment period (double-blinded administration) of rabeprazole 10 mg, 20 mg, 40 mg, or placebo, once daily after breakfast.
Participants by arm
| Arm | Count |
|---|---|
| Rabeprazole 10 mg Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks. | 77 |
| Rabeprazole 20 mg Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks. | 76 |
| Rabeprazole 40 mg Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks. | 74 |
| Placebo Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks. | 80 |
| Total | 307 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 3 | 1 |
Baseline characteristics
| Characteristic | Rabeprazole 10 mg | Rabeprazole 20 mg | Rabeprazole 40 mg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 46.9 years STANDARD_DEVIATION 14.9 | 50.2 years STANDARD_DEVIATION 16.5 | 46.4 years STANDARD_DEVIATION 14.8 | 45.8 years STANDARD_DEVIATION 15.5 | 47.3 years STANDARD_DEVIATION 15.5 |
| Sex: Female, Male Female | 43 Participants | 40 Participants | 47 Participants | 44 Participants | 174 Participants |
| Sex: Female, Male Male | 34 Participants | 36 Participants | 27 Participants | 36 Participants | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 28 / 85 | 20 / 85 | 31 / 83 | 22 / 85 |
| serious Total, serious adverse events | 0 / 85 | 1 / 85 | 1 / 83 | 1 / 85 |
Outcome results
Primary
Rate of Complete Dyspepsia Symptom Relief
The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants.
Time frame: Up to 8 Weeks (including 7 days prior)
Population: Per Protocol Set (PPS) population defined as those participants who complied with the study protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rabeprazole 10 mg | Rate of Complete Dyspepsia Symptom Relief | DSQ (n= 76, n= 75, n= 74, n= 78) | 22.4 Percentage of Participants |
| Rabeprazole 10 mg | Rate of Complete Dyspepsia Symptom Relief | Diary Recordings (n= 77, n= 76, n=74, n=80) | 22.1 Percentage of Participants |
| Rabeprazole 20 mg | Rate of Complete Dyspepsia Symptom Relief | Diary Recordings (n= 77, n= 76, n=74, n=80) | 28.9 Percentage of Participants |
| Rabeprazole 20 mg | Rate of Complete Dyspepsia Symptom Relief | DSQ (n= 76, n= 75, n= 74, n= 78) | 29.3 Percentage of Participants |
| Rabeprazole 40 mg | Rate of Complete Dyspepsia Symptom Relief | DSQ (n= 76, n= 75, n= 74, n= 78) | 27.0 Percentage of Participants |
| Rabeprazole 40 mg | Rate of Complete Dyspepsia Symptom Relief | Diary Recordings (n= 77, n= 76, n=74, n=80) | 27.0 Percentage of Participants |
| Placebo | Rate of Complete Dyspepsia Symptom Relief | DSQ (n= 76, n= 75, n= 74, n= 78) | 17.9 Percentage of Participants |
| Placebo | Rate of Complete Dyspepsia Symptom Relief | Diary Recordings (n= 77, n= 76, n=74, n=80) | 17.5 Percentage of Participants |
Secondary
Rate of Satisfactory Symptom Relief
The rate of satisfactory symptom relief according to the DSQ defined as scores of \<= 2 for all four major dyspepsia symptoms at week 8 and the diary recordings defined as a frequency of \<= 1 day for all four major dyspepsia symptoms during the 7 days before week 8. Lastly, treatment success according to the participants' impression questionnaire where participants answered yes or no when asked if given the choice, whether they would want to continue to take the study drug after clinical trial completion. Values presented as percentage of participants.
Time frame: Up to 8 Weeks (including 7 days prior)
Population: Per Protocol Set (PPS) Population: defined as those participants who complied with the study protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rabeprazole 10 mg | Rate of Satisfactory Symptom Relief | Treatment Success (n=76, n=75, n=74, n=78) | 72.4 Percentage of participants |
| Rabeprazole 10 mg | Rate of Satisfactory Symptom Relief | DSQ (n=76, n=75, n=74, n=78) | 42.1 Percentage of participants |
| Rabeprazole 10 mg | Rate of Satisfactory Symptom Relief | Diary Recordings (n=77, n=76, n=74, n=80) | 37.7 Percentage of participants |
| Rabeprazole 20 mg | Rate of Satisfactory Symptom Relief | Treatment Success (n=76, n=75, n=74, n=78) | 85.3 Percentage of participants |
| Rabeprazole 20 mg | Rate of Satisfactory Symptom Relief | Diary Recordings (n=77, n=76, n=74, n=80) | 48.7 Percentage of participants |
| Rabeprazole 20 mg | Rate of Satisfactory Symptom Relief | DSQ (n=76, n=75, n=74, n=78) | 45.3 Percentage of participants |
| Rabeprazole 40 mg | Rate of Satisfactory Symptom Relief | DSQ (n=76, n=75, n=74, n=78) | 39.2 Percentage of participants |
| Rabeprazole 40 mg | Rate of Satisfactory Symptom Relief | Diary Recordings (n=77, n=76, n=74, n=80) | 39.2 Percentage of participants |
| Rabeprazole 40 mg | Rate of Satisfactory Symptom Relief | Treatment Success (n=76, n=75, n=74, n=78) | 64.9 Percentage of participants |
| Placebo | Rate of Satisfactory Symptom Relief | Treatment Success (n=76, n=75, n=74, n=78) | 59.0 Percentage of participants |
| Placebo | Rate of Satisfactory Symptom Relief | DSQ (n=76, n=75, n=74, n=78) | 28.2 Percentage of participants |
| Placebo | Rate of Satisfactory Symptom Relief | Diary Recordings (n=77, n=76, n=74, n=80) | 30.0 Percentage of participants |